The Effects of Exercise and Nutrition Interventions on Platinum Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry (R21)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- CIPN-20 sensory subscale
研究概览
简要总结
Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of platinum-based chemotherapy, often used to treat gastrointestinal cancers. Unfortunately there are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exercise vs. nutrition education on CIPN, to systematically investigate the potential roles of inflammation and interoception, and to obtain data with a more accurate effect size to inform a future study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(subjects must…)
- •Have a diagnosis of cancer
- •Be scheduled to receive platinum chemotherapy (specifically oxaliplatin or cisplatin) without other neurotoxic chemotherapy (taxanes, bortezomib, thalidomide). Patients may be enrolled before their first (preferred), second, or third infusion of neurotoxic chemotherapy
- •Be able to read English
- •Be ≥18 years
排除标准
- •(subjects must not…)
- •Be performing regular exercise, which is any planned physical activity (e.g., brisk walking, aerobics, jogging, bicycling, swimming, rowing, weight lifting, resistance training, yoga, pilates, etc.) performed to increase physical fitness. To be considered exercise, physical activity should be performed 3-5 times per week for 20-60 minutes per session and should be done at a level that increases your breathing rate and causes you to break a sweat.
- •Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in maximal physiological fitness testing and a low/moderate intensity home-based walking and progressive resistance exercise program.
- •Have planned surgery or radiation treatment in the 12 weeks after baseline.
- •Additional exclusion criteria only for patients completing MRI (approximately 40 of 60 enrolled subjects; subjects must not…)
- •Have current or prior cancer in the spine, brainstem, or brain (to allow standard brain MRI analysis)
- •Have contraindications for MRI scanning (pacemaker, ferrous metal implants, pregnancy, etc. note that most port-a-caths are safe for MRI scanning)
研究组 & 干预措施
EXCAP Exercise
Exercise for Cancer Patients (EXCAP©®) involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program.
干预措施: EXCAP Exercise (Behavioral)
Nutrition Education
Nutrition education involves equal time and attention as the exercise arm, but the content covers nutrition for cancer patients and lacks an exercise prescription.
干预措施: Nutrition Education (Behavioral)
结局指标
主要结局
CIPN-20 sensory subscale
时间窗: Time point 2 (approximately 6 weeks), controlling for baseline value
CIPN-20 sensory subscale (Postma et al 2005). The subscale includes 9 questions, each rated 1-4, and the score ranges from 9-36 with larger values reflecting more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN).
次要结局
- Cold-induced pain(Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline)
- Numbness and tingling(Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline)
- Sensory, motor, and autonomic symptoms of CIPN(Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline)
- Sensory loss(Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline)
- CIPN-20 sensory subscale(Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline)
研究者
Ian Kleckner, PhD, MPH
Associate Professor
University of Maryland, Baltimore